Risk Mitigation During Medication and Specialty Shortages, Equipment Recalls

By Heather Edwards, RN

As many in health care will recall, the nation saw a dramatic shortage of iodine in 2022, after a two-month COVID-19 lockdown resulted in manufacturing interruptions. Doctors, clinics, and hospitals scrambled to respond to the shortage, contending with delays in treatments, patient backlogs, and less-than-ideal alternatives. Rallying to provide guidance, organized medicine stepped in, with the American College of Radiology Committee on Drugs and Contrast Media offering recommendations to help imaging specialists address the shortage until supplies could resume.

Medication shortages in the U.S. have become increasingly prevalent in recent years, predating the pandemic. But that’s not all: The U.S. is also seeing an increase in medical equipment recalls and delayed procedures due to local or statewide staffing shortages. These events can have consequences for patient care, from delays in care to missed diagnoses. Considering that claims are often filed years after an adverse event occurs, it is essential for physicians and physician organizations to develop appropriate risk mitigation strategies for health care shortages and recalls.

Medication shortages

Drug shortages can be caused by many factors. As the medications listed on the U.S. Food and Drug Administration Drug Shortages Database are constantly changing, the level of threat to the patient can range from minimal to devastating. Consult recognized societies and associations when available. They may provide best practice recommendations.

The recommendations offered by the American College of Radiology in response to the iodine shortage in 2022 may contain useful principles that can be applied to other situations, as well. Those recommendations advised specialists:

• Use alternative studies, with or without contrast, appropriate for patient circumstances.
• Use alternative versions of contrast media or sourcing from different vendors.
• Discuss strategies that may be appropriate for repackaging of higher-volume single-use vials (involving infection control and pharmacy).
• Reduce waste by minimizing individual doses.
• Identify studies for which higher concentration agents are needed for optimal visualization.
• Use recognized and approved alternatives to nonionic contrast for oral, rectal, and genitourinary administration.
• Collaborate with other departments that use iodine-based agents in order to prioritize use.

Further, if contrast media was in short supply, specialists were advised to develop mitigation, prioritization, and procurement strategies, as well as communicate with ordering physicians. Since substitutions in the contrast media drug, the concentration, or the indications may have led to confusion and resulted in administration errors, the society recommended that a “contrast time-out” be added to any imaging procedure to ensure that the correct agent, amount, and concentration is being used.

Documentation and communication

Concerns arise for malpractice exposure when a needed medication is not available or if a substitution is used to bridge the gap. Documentation and creating a detailed plan play critical roles for patient safety. Share the plan with staff involved in patient care and make sure it includes documentation standards. Include the following type of information in the patient’s medical record, adapting details to specific circumstances:

• The health care crisis or situation impacting patient care.
• Alternative medications or studies considered and used in accordance with any revised clinical guidelines.
• Patient factors taken into consideration
• Shared decision-making with the patient.
• Any deviations from the norm (dosage, concentration, medication, changes in studies, etc.).
• The use of procedural “time-out” prior to administration in cases of a major deviation.
• Plans for future care.

The Institute for Safe Medication Practices, ECRI, and the FDA have resources available to help manage drug shortages. They can assist with developing policies and processes and help identify when limiting or extending beyond use date should be used as a countermeasure.

Specialty care shortages

Lack of access to specialty care is another challenge in health care that can have devasting consequences for patients. To ensure patient safety, it is vital that staff involved are aware of the situation, of your mitigation plan, and of the required documentation and ongoing interim care until a patient can be seen. Delays in care should be clearly documented in the patient record. Considerations:

• Make sure your patient understands the situation and be certain that all risks are known to the patient if surgery or a referral will be delayed.
• Provide your patient with options. For example, you can offer to refer them to a specific physician who can treat them at a different facility if you do not have privileges at that organization. If necessary, consider appropriate physicians or practitioners in nearby communities. Save in the patient’s chart a record of all communication attempts with other physicians and clinics for referral.
• If the patient understands the risks and chooses to delay care rather than go to a different physician, document the options you offered and the fact that the patient chose to delay care. Summarize the plan for future patient care.
• Indicate the current status of the patient.
• Implement a system to track overdue surgeries, procedures, and appointments and create a process for ongoing monitoring of patients who are waiting. It is important to document any change in a patient’s condition that would indicate a necessary escalation in care.

Lack of access to specialty care is not an opportunity to reduce safety criteria so patients can be seen more quickly. For example, a patient with comorbidities requiring a hospital colonoscopy cannot get their procedure in an ambulatory surgery center to avoid delay. Patients must still meet the criteria for care in an ASC.

Equipment recalls

The variety in recall types in health care underscores the importance of implementing a plan throughout your organization. Recalls can impact a small or large number of your patient population. Patients’ dependence on mechanical and electronic technologies is increasing, and a sudden loss of access to these, as well as to medications, can be challenging. Managing the risks associated with recalls is a critical aspect of patient safety. Considerations:

• Develop a recall policy that identifies state and federal requirements for documentation of lot numbers, serial numbers, and other identifying information needed to effectively manage medication and equipment recalls.
• Create a plan that outlines the procedures for managing the specific recall. Include details such as identification, communication, notification, equipment retrieval, and documentation.
• Work closely with the equipment manufacturers or suppliers to ensure you understand their guidelines, the recall classification (voluntary or mandatory; not likely to harm or serious risk), and the support they will provide.
• Implement a system to quickly identify the recalled equipment, implant, or medication.
• Identify patients affected by the recall. When possible, have alternative medication, equipment, or procedures in place to avoid disruption of care.
• Develop a clear message that all staff should use when communicating or discussing the recall, including appropriate details such as:
  • What the equipment or implant or medication is (model number, manufactured date, lot number, etc.)
  • Reason for the recall
  • Potential risks
  • Steps the patient should take
  • Point of contact
• Choose the appropriate communication method(s):
  • Personalized letters
  • Phone calls
  • Patient portal
  • SMS alert
• Ensure that staff is prepared for a potential influx of calls and inquiries. Staff should be well-informed about the recall and trained on how to handle patient concerns.
• Schedule appointments, if necessary, for alternative treatment or checkup, if indicated.
• Maintain thorough records of all recall-related activities, including notification received, actions taken, and the disposition of recalled equipment.
• Send follow-up communication to all patients who have not responded or have not taken the necessary steps. Document all patient communications in the patient record.

Depending on the nature of the recall, a consent or declination-of-care document may be needed.

Every situation is unique and may call for tailored support. Do not hesitate to reach out to Physicians Insurance or your professional liability coverage provider for personalized assistance and guidance.

Heather Edwards, RN, CPHQ, is a senior clinical consultant with Physicians Insurance. Physicians Insurance members can access detailed guidance including sample documentation at phyins.com/resources.

This article was featured in the May/June 2025 issue of WSMA Reports, WSMA’s print magazine.